臨床研究等提出・公開システム

Date of registration	Oct. 03, 2024
Last modified on	Oct. 03, 2024
Trial ID	jRCT1032240363

Scientific Title	Post-marketing observational study on the efficacy and safety of NeuroGuideWire for the treatment of stroke and aneurysm (C-AISIA)
Public Title	Post-marketing observational study on the efficacy and safety of NeuroGuideWire for the treatment of stroke and aneurysm (C-AISIA)

Contact for Scientific Queries	Name	Ooishi Hidenori
	Affiliation	Juntendo University School of Medicine Juntendo Clinic
	Address	3-1-3 Hongou, Bunnkyou-ku, Tokyo, Japan
	Telephone	+81-3-3813-3111
	E-mail	investigationclinical.001@gmail.com
Contact for Public Queries	Name	Ooishi Hidenori
	Affiliation	Juntendo University School of Medicine Juntendo Clinic
	Address	3-1-3 Hongou, Bunnkyou-ku, Tokyo, Japan
	Telephone	+81-459112011
	E-mail	investigationclinical.001@gmail.com

Recruitment status	Complete


Anticipated date of first enrollment		Dec. 01, 2023
Actual date of first enrollment		Dec. 01, 2023
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who have undergone endovascular treatment using a neuroguidewire for ischemic stroke or cerebral aneurysm from January 1, 2022 to the date of Ethics Committee approval. 2) Patients who have given consent for the use of their medical information.
	Exclusion Criteria	1) Patients who used medical devices not approved in Japan 2) Patients under 18 years of age and those who need to obtain consent from a substitute 3) Patients whom the principal investigator considers to be unjustified as research subjects.
	Age Minimum	18age old over
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		acute ischemic stroke and brain aneurysm
Health Condition(s) Keyword		Ischemic Stroke, AIS, stroke, Intracranial Aneurysm
Health Condition(s) Code		Ischemic Stroke / Intracranial Aneurysm
Primary Outcome(s)		Efficacy: success rate of microcatheter induction Definition of successful induction: a successful induction is considered when any of the following (1) to (4) are met. (1) Was the microcatheter tip able to reach the aneurysm? (2) Was the microcatheter tip or the balloon portion of the balloon catheter able to reach the distal portion beyond the aneurysm? (iii) Was the tip of the microcatheter able to reach just before the site of occlusion or stenosis? (iv) Was the microcatheter tip able to reach the distal portion beyond the site of occlusion or stenosis?
Secondary Outcome(s)		Efficacy 1) Reach of the research device (guidewire) to the target site 2) Need for replacement with other neuroguidewire 3) Microcatheter or balloon catheter used in combination (product name) Safety 1) Failure during the procedure related to the research device. 2) Whether or not there are any adverse events that can not be ruled out as causally related to the research device.

Primary Sponsor	Asahi Intecc Co., Ltd.

Name of Certified Review Board	Research and Ethics Committee, Faculty of Medicine, Juntendo University School of Medicine
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-3813-5018
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Sept. 26, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None